Bellarmine University Institutional Review Board (IRB) Handbook Policies and Procedures for the Review of Research Involving Human Subjects

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Bellarmine University Institutional Review Board (IRB) Handbook Policies and Procedures for the Review of Research Involving Human Subjects"

Transcription

1 Bellarmine University Institutional Review Board (IRB) Handbook Policies and Procedures for the Review of Research Involving Human Subjects Last Reviewed and Approved 5/19/14

2 1. Purpose & Mission Human research oversight and compliance at Bellarmine University is administered by the Institutional Review Board (IRB). The IRB is composed of full-time faculty members and at least one non-bellarmine associated member of the community. Members are appointed by and report to the Provost (or designee). Guidelines for IRB operations are outlined in Title 45 Part 46 of the Code of Federal Regulations and by the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services. The Common Rule. On 6/18/91, 17 Federal Departments and Agencies adopted a common set of regulations known as the Federal Policy for the Protection of Human Subjects. This is often referred to as the Common Rule. The common rule requires that any institution requesting and receiving funds from a federal department or agency for research involving human subjects must assure that the research is reviewed and approved by the University s Institutional Review Board. This is based on internationally recognized ethical principles originally published on 4/18/79 in the Belmont Report. These principles are: Respect for persons this incorporates at least 2 ethical convictions: first, that individuals should be treated as autonomous agents; and second, that persons with diminished autonomy are entitled to protection (Thus the need to obtain informed consent). Beneficence this anticipates that persons will be treated in an ethical manner not only by respecting their decisions, but also by making efforts to secure their well-being 2 general rules: 1) do no harm; and 2) protect from harm by maximizing anticipated results and minimizing possible risks of harm. Justice- this requires that the benefits and burdens of research be distributed fairly (particularly in the selection of research subjects). As such, the mission of the Bellarmine University IRB is to protect the community and individual participants. In the process, the IRB ensures that the research activities of all Bellarmine University affiliates complies with federal regulations and meets the highest ethical standards. Any person participating as a subject in a research study is entitled to informed consent, privacy, and confidentiality with respect to the research data collected. 2. Definition of Research and Principal Investigator (PI) Research is defined as a systematic investigation, including testing and evaluation, designed to develop or contribute to generalizable knowledge. All human subject activities meeting this definition are within the jurisdiction of the IRB. As such, research involving human subjects must be reviewed and approved. Exceptions to IRB approval would be those projects or activities that do not meet the federal definition of research based on the U.S. Department of Health and Human Services decision tree (see Chart 1 also reproduced in Appendix B). The Principal Investigator (PI) for Research involving Human Subjects, performed on the Bellarmine University campus or any affiliated facility, must be a member of the faculty or full-time staff. Students, graduate or undergraduate, are not allowed to serve as PI. They are welcome to serve as co-investigators, but all IRB forms must be approved, signed, and submitted by the PI. All formal communication regarding an IRB submission shall be handled thorough the PI. 3. Composition & Quorum The IRB will be composed of no fewer than five members including the Chair and Vice-Chair. To ensure compliance with federal regulations and ensure broad representation of the campus community, the BU committee will include at least one regular member from the following 7 constituencies: 1) Sciences, 2) Social Sciences, 3) Education, 4) Nursing, 5) Physical Therapy, 6) a non-science disciplines such as the arts, communications, and humanities, and 7) the community at large. Note, one member may be able to satisfy more than one of these constituency requirements. As required by governing regulations, the community member (and/or any of their immediate family members) must not have a formal affiliation with the institution. The committee will appoint 3-4 alternates to assist with reviews in those IRB Handbook Last Revised 1/09/15 Page 1

3 situations where a potential conflict of interest might be identified or declared. Alternates will participate at the discretion of the Chair. Additionally, the IRB (or the chair, or an assigned expedited reviewer) may consult with outside experts in a given field in situations where a submitted protocol may be reasonably beyond the expertise of the member(s). Quorum will be defined as no less than three participating members with at least one of the attendees being a non-scientist and one unaffiliated member of the community. In limited and extra-ordinary situations, IRB members may, with prior approval of the Chair and consent of the majority of IRB members in attendance, participate via teleconference to obtain a quorum. A passing vote shall be defined as one receiving a simple majority of those members present. The Chair and Vice-chair are voting members of the committee. 4. Appointment Procedures & Terms The Office of Academic Affairs will solicit volunteers annually and membership will ordinarily be selected from the obtained pool of volunteers. Members and alternates will be appointed for two -year terms by the Provost (or designee). To ensure consistency, the terms will be staggered with at-least three permanent members appointed in even years and at-least two members appointed in odd years. Alternates will be appointed in a similar fashion. Should a permanent member resign or be removed from the committee, the Provost (or designee) will consult with the IRB Chair prior to appointing a replacement. The Chair and Vice-Chair of the IRB will be appointed by the Provost (or designee). 5. Meeting Schedule The committee will meet at-least once per semester, and as needed (inclusive of a single July meeting on the second Tuesday of the month) to facilitate the review of protocols requiring full review. When and where electronic resources can be used to increase the efficiency of the review process, technology shall be used at the discretion of the IRB Chair insofar as the principles of committee composition and quorum are preserved and all regular members (or designated alternates, if appropriate) have the means to participate. Additionally, the IRB may deploy committee approved practices associated with exempt or expedited reviews to increase efficiency as long as human subjects are protected. 6. Functions, Responsibilities, & Authority The IRB will review and approve investigator protocols as well as exercise continuing review of ongoing research. As part of its review process, the IRB has the authority to recommend modifications prior to approval to ensure the safety of the public. Likewise, the IRB may vote to not approve proposed research as the risks may be deemed unacceptable. Additionally, the IRB is obligated to investigate non-compliance issues and has the authority to suspend research activities and may recommend sanctions related to research performance and/or misconduct to the Office of Academic Affairs. The Chair has responsibilities for scheduling and chairing meetings of the IRB, assigning expedited reviews, and issuing decision letters. The University will provide the Chair with administrative support to ensure consistent record keeping and overall compliance with governing regulations. Additionally, the Chair may delegate duties to the Vice-chair, as needed. 7. Training Opportunities & Commitment Training All IRB members and alternates are required to have completed human subjects training within 2 years of reviewing IRB submissions. Likewise, all investigators are required to have completed human subjects training prior to IRB submission. The IRB is committed to ensuring training and no submitted protocols will be approved without a IRB Handbook Last Revised 1/09/15 Page 2

4 verification certificate from one of the approved tutorials below. Certificates will be kept on file in the IRB office. All investigators are required to renew their human subjects training every 3 years. In addition to the tutorials above, investigators are encouraged to view training videos prepared by the US Office for Human Research Protections. The videos can be viewed at: 8. Informed Consent According to federal regulations, informed consent must include the following basic elements and participant consent must be documented: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation is offered and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, who pays for such treatment, and where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Source: 45 CFR To assist investigators with meeting the informed consent requirements outlined above, the IRB has created two templates (copies can be found in Appendix A). The first template can be used for standard survey and interview research. The second template has been designed to address issues of informed consent associated with more complex studies involving interventions, biological sampling, and/or studies dealing with vulnerable populations. The Bellarmine University IRB has created a checklist that ensures all basic elements are included for the second consent form. This checklist must be filled out by the PI and included with the submission. Assent & Vulnerable Populations. Documenting assent of vulnerable populations (such as minors, individuals with cognitive disabilities, and prisoners) following permission to recruit vis-à-vis the approved informed consent process is critical to protecting the rights and safety of all research subjects. The IRB requires the assent of participants be documented using a process that is developmentally appropriate and formal. Assent means an affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (45 CFR (b)). Given the wide range of environments where research with vulnerable populations might occur, investigators are able to propose a variety of mechanisms or practices that are appropriate as documented in the recognized literature. IRB Handbook Last Revised 1/09/15 Page 3

5 The IRB recognizes that the assent process will vary depending on the intervention type and population. For example, the process will vary for minors depending on the age, maturity, and psychological state of the child. 1 All investigators must present a protocol that articulates how vulnerable populations will be informed of their rights to participate or not (i.e., a proposed script). Note that nonmedical, minimal-risk studies (e.g., institutional or educational research) will sometimes not have an assent form, but instead use a verbal process or a signal for the child's assent, along with a written parental permission. In these cases, all investigators must: 1.) Provide a description of the resources, activities, or options available to non-participants; and 2.) Document the assent of willing participants (such as a summary list of participants with a reference to the total number of non-participants, participant sign up, or individual signatures on formal assent forms). As part of the assent process, all investigators must also articulate the options available to non-assenting individuals who will not participate. In the end, the objective of the IRB is to ensure that partner organizations (schools, prisons, or health care facilities), legal guardians, and vulnerable populations are protected and not exploited as samples of convenience. 9. Investigations of Non-Compliance, Reporting, and Actions The IRB has a duty to investigate all cases of noncompliance in human subjects research. Notification of suspected noncompliance may occur during the review of submitted protocols, community reports, inadvertent disclosures, or report of an adverse event. Once the IRB has been made aware of potentially noncompliant research, the Chair must make an initial determination as to whether or not the noncompliance: 1) constitutes serious or continuing noncompliance with IRB rules and federal regulations, 2) poses immediate risk of injury to the community, 3) a significant adverse event has occurred; 4) continuation of the research exposes subjects to risk that exceeds minimal risk; or 5) the noncompliance is non-serious and poses only minimal risk. If the Chair makes a determination other than non-serious (#5), the Chair must report the noncompliance to the designated institutional officer and inform the PI to cease all study activities immediately. In all cases, the Chair will: 1) Contact the PI and discuss the situation, 2) Endeavor to determine if noncompliance has occurred and resolve the non-compliance issue (i.e., situations best described as non-serious and non-continuing where submission of a new protocol or revision of an existing protocol would be appropriate and/or the non-compliance was minor and/or inadvertent), 3) If the noncompliance cannot be resolved informally or a full investigation by the Committee is warranted, the Chair will collect relevant documentation for presentation to the Committee, 4) the full Committee will review the documents and make a determination inclusive of assigning sanctions (if appropriate), and 5) the Committee will notify the PI of the outcome of the investigation and sanctions (if any). Sanctions may include termination of a study, suspension of study, preventing a PI from disseminating data collected, additional training, and/or the modification of a protocol. In addition to IRB action, the University may impose other appropriate sanctions consistent with the University Handbook. 1 While protocols for documenting and obtaining assent may vary by discipline, the IRB generally recommends that assent be obtained from any child with an intellectual age of 7 years or more, in addition to obtaining written parental permission. A distinction can be made for assent protocols including children between the ages of 13 and 17 years (i.e., an adolescent written assent form including the same elements as in the adult consent form or parent permission form with age-appropriate language), between the ages of 7 and 12 years (i.e., a briefer, piloted written assent mechanism that may include large font, simple schemas, and pictures), and children under the age of 7 (i.e., a witnessed verbal assent form in some cases). Variations from the general strategies and methods outlined above should be documented by the investigator and cite the appropriate peer reviewed literature. IRB Handbook Last Revised 1/09/15 Page 4

6 Any and all adverse events must be reported promptly (within ten days) to the IRB and investigated using the general process outlined above. Based on 45CFR46.103(b)(5), an adverse event refers to any unanticipated problems or events that involve increased risk, a breach in approved protocol, or other injury associated with human subjects research. Serious adverse events include death or the combination of all of the following conditions: the event was unexpected, serious (physical injury, psychological disability, or other event requiring hospitalization), and possibly related to the research. Adverse events could result in the suspension or termination of an approved study or the modification of an existing protocol. The IRB is required to report all adverse events and cases of noncompliance to sponsors and the Office of Human Research Protections that are: 1) serious or continuing noncompliance; 2) significant adverse events beyond minimal risk; or 3) associated with the suspension or termination of an IRB approved protocol. 10. Changing this document Changes to this document (The Bellarmine IRB Handbook) may be made provided the suggestions are disseminated to all current members for their review and comment. After a 1 week period of review, the Chair may call for a vote. Changes shall be passed by a simple majority of the Committee members. The date of the latest revision should be noted in the footer. IRB Handbook Last Revised 1/09/15 Page 5

7 Appendix A: IRB Submission Forms The following forms are available on the IRB website for PI s wishing to submit their proposal for review. All relevant forms (including the Human Subjects Research Training certificate and CV s for all investigators) must be completed and submitted before formal IRB review will begin. A clerical screening will be performed by the IRB secretary and the PI will be informed of any omissions. Initial review by the IRB Chairman will only occur when the submission is complete. 1. Submission Checklist (rev. 10/24/13) 2. IRB Submission Summary Form (rev. 10/24/13) 3. Risks and Benefits Form (rev. 10/24/13) 4. Conflict of Interest Form (rev. 10/24/13) 5. Survey Consent Template (rev. 10/24/13) 6. Std Consent Form Template (rev. 10/24/13) 7. Std Consent Form Checklist (rev. 10/24/13) 8. Amendment or Termination Form (rev. 5/19/14) 9. nonbu IRB Submission Summary Form (rev. 6/14/13) 10. Short App for Exempt Review (rev. 5/19/14). IRB Handbook Last Revised 1/09/15 Page 6

8 Appendix B: IRB Review Process by Type & General Timelines 1) Clerical Screening: Submissions are first checked for completeness and accuracy by the IRB secretary. The PI is alerted regarding any omissions. 2) Initial Review by Chair (or designee): Completed submissions are reviewed by the Chairman in order to determine a) Does the project qualify as Human Subjects Research? If NO- inform the PI and keep record of the submission. If YES- proceed to next step. If UNSURE- Consult with other IRB members or Assistant Vice-President for Research and Academic Affairs b) Does the Research involve more than minimal risk? (i.e. risks one would typically encounter in daily living) If NO- Proceed to step c. If YES- The study must be reviewed by the Full IRB Committee. Have the file scanned and sent to the Committee with a meeting request. A Standard Informed consent will be needed unless the PI applies for an exemption per 45 CFR (d). The study will also need to be reviewed annually. IF UNSURE- Consult with other IRB members or Assistant Vice-President for Research and Academic Affairs c) Determine if the study meets the criteria for Exempt Review or Expedited Review. Utilize the 11-page flowchart published by the OHRP on 9/24/04- OHRPdecisionFlowWcitations.pdf (attached at the end of this Appendix). Expedited Review can be performed by the Chair or the chair s designee. The submission should be scanned and sent to a member along with a Reviewer Decision Worksheet (copy attached at the end of this appendix). Consent forms (either Survey OR Standard Consent) are usually required unless the PI applies for an exemption per 45 CFR (d). The study will need to be reviewed annually. Exempt studies are NOT exempt from review. They are simply exempt from annual review. All human subjects research must be reviewed by the IRB. However, research that is less than minimal risk may be reviewed by a short form (see form #10 in Appendix A). d) If the Chair or the Committee suggests changes in the protocol or consent, the Chair shall alert the PI. Once the Chair or committee are satisfied with the submission and approve the research, the Chair shall inform the PI (with cc to the Assistant Vice-President for Research and Academic Affairs). IF the work is not approved, the Chair shall inform the PI with cc to the Assistant Vice-President for Research and Academic Affairs. The submission and approval or rejection letter shall be kept on file in the IRB office. IRB Handbook Last Revised 1/09/15 Page 7

9 Details on the Types of Reviews are included below: Full Review Full reviews require a completed IRB checklist, submission summary form, a comprehensive protocol description and an example of informed consent on Bellarmine letterhead. Full review is required in all cases where research exposes subjects to more than minimal risk. Examples may include (but are not limited to) research involving deception, individuals with cognitive disabilities, prisoners, or the infirmed, as well as any protocols where body specimens are obtained, or sensitive information requested. All full review of protocol must be approved at a scheduled meeting of the IRB. The IRB may vote to: 1.) Approve; 2.) Approve with minor revisions; 3.) Request additional information or clarifications for consideration at later meeting; or 4.) Not approve the research protocol. Ordinarily, full reviews (not necessarily approval of the protocol per se) should be completed within twenty-eight (28) working days of receiving a completed submission, depending upon the timeliness of investigator responses to IRB (or IRB chair) inquiries. Please note, protocols requiring a summer review will not be considered by the IRB until July. As such, protocols requiring action prior to the end of the Spring semester should be submitted no later than mid-april. If approved, the PI is required to submit an annual Progress Report. Any modifications or amendments to an approved research protocol require prior approval and an amendment form must be submitted to the IRB chair. The IRB chair or his/her designee may approve a modification or request the modification be reviewed at a scheduled IRB meeting. Expedited Review Expedited reviews require a complete IRB checklist, a submission summary form, a comprehensive protocol description and an example of informed consent. 2 Studies that entail non-exempt research involving minimal or less than minimal risk to subjects, or non-invasive research, may be eligible to undergo an expedited review at the discretion of the IRB chair and will be reviewed by the chair or an assigned IRB member. As part of the expedited process, the reviewer and/or the chair may make inquiries of the PI and suggest revisions prior to issuing a decision. The assigned reviewer may recommend to the chair that the protocol be: 1.) Approved; 2.) Approved with minor amendments; or 3.) Forwarded to the committee for a full IRB review. Ordinarily, expedited reviews are completed within fourteen (14) working days of receiving a completed submission, depending upon the timeliness of an investigator to IRB inquiries. If approved, the PI is required to submit an annual report to the IRB. Any modifications or amendments to an approved research protocol require prior approval and an amendment form must be submitted to the IRB chair. The IRB chair or his/her designee may approve a modification or request the modification be reviewed by at a scheduled IRB meeting. IRB Handbook Last Revised 1/09/15 Page 8

10 Expedited reviews should be approached with caution when the reviewer feels they lack the appropriate expertise to judge the submission. The chair should be asked to redirect the review to a more qualified member of the committee. Independent, unaffiliated experts can also be consulted by the IRB chair or designee. In cases where uncertainty may still exist following investigator inquiries and/or an external consult, a full IRB committee review would be necessary. Exempt Review Exempt reviews require a PI to submit an Exempt Short Form Application. The short form is an abbreviated process whereby the PI can demonstrate the research meets the criteria for an exemption. The Chair or her/his designee may: 1.) approve the protocol; 2.) approve with minor revisions; or 3.) Request a full protocol be submitted pursuant to the expectations and requirements of either expedited or full review. Ordinarily, an exempt review is completed within seven (7) working days of receiving a completed submission. Pursuant to the governing regulations, the exemption permits an on-going study to occur over a 12 month period and no annual report is required. Studies lasting longer than 12 months are required to submit an amendment of the study seeking a time extension. Studies involving minors or other vulnerable populations are not normally eligible for Exempt Review except for as outlined in the exempt application as approved by the CFR language. Restarting a Protocol A PI may restart a previously terminated study by submitting an Amendment form (form # 8 in Appendix A). Participating in a Study that has been Approved by a nonbu IRB A PI may participate in a study (e.g. as a satellite center) that has been approved by an IRB other than the Bellarmine IRB (a.k.a. a nonbu IRB) but prior to doing so, he or she must inform the Bellarmine IRB by submitting the following: 1) A signed and completed nonbu IRB Submission Summary Form (Form # 9 in Appendix A) 2) A copy of the protocol for the research 3) A copy of the nonbu IRB approval letter. The Bellarmine IRB has the authority to ask for additional information and to decide if the nonbu IRB approval is acceptable or not. IRB Handbook Last Revised 1/09/15 Page 9

11 Appendix C: Community-based Research & Partnerships The IRB recognizes the increasing importance of community-based teaching, learning, & research. As such, the IRB may recognize, at its discretion, formal partnership agreements from which research might one day emerge as a result of public service or other academic activities. As part of this process, the IRB may permit a program (not an individual researcher) to develop a memorandum of understanding (MOU) associated with partnership activities (particularly in clinical and/or professional environments) where the risk is determined to be (or reasonably expected to be) minimal or less than minimal risk. The MOU must generally describe the scale and scope of approved activities. The proposed partnerships and resulting MOU must also be institutional and programmatic and investigator specific. The intent of the MOU approach is to ensure compliance with human subjects research rules. As such, any activities that would ordinarily require a full IRB review cannot be covered by the MOU. [Include a sample copy of an MOU, when one is created and create a form that would be used to notify the IRB when the MOU is being utilized by a particular PI.] IRB Handbook Last Revised 1/09/15 Page 10

12 Appendix D: Class Projects & Student Research The intent of class projects is to provide students with an important educational experience and not professional dissemination. As part of the educational process, students enrolled in courses that require minimal risk human subjects or related community-based research (i.e., interviews, surveys, program assessments, and so on) are not required to obtain IRB approval. Nevertheless, all students are expected to receive appropriate training and comply with the principles of informed consent. All course based research projects must be approved by the instructor. All projects that exceed minimal risk and would ordinarily require expedited or full review (i.e., sensitive data, etc ) must receive IRB approval. Independent student research, such as a thesis, dissertation, or culminating capstone experience, are not defined as class projects and IRB review and approval is required. While non-irb reviewed class projects cannot ordinarily be published or presented outside of the institutional context of Bellarmine University inclusive of community partnerships, minimal risk studies and subsequent research derived from prior class projects may be eligible for approval as existing data at the discretion of the IRB Chair (or full IRB) and provided both human subjects training of the students and informed consent of the participants are documented. Should the intent of a class-based or community-based project change from primarily educational to research as defined by the IRB, all project activity (i.e., surveys, interviews, etc ) would need to cease until such time as IRB approval is obtained. IRB Handbook Last Revised 1/09/15 Page 11

MEREDITH COLLEGE INSTITUTIONAL REVIEW BOARD GUIDELINES FOR THE PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH

MEREDITH COLLEGE INSTITUTIONAL REVIEW BOARD GUIDELINES FOR THE PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH MEREDITH COLLEGE INSTITUTIONAL REVIEW BOARD GUIDELINES FOR THE PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH I. Introduction Recognizing its responsibility to provide measures to reasonably protect individuals

More information

Student Classroom Projects Involving Human Subjects (Guidance for Faculty)

Student Classroom Projects Involving Human Subjects (Guidance for Faculty) University of New England Institutional Review Board (IRB) Student Classroom Projects Involving Human Subjects (Guidance for Faculty) The University of New England (UNE) supports a wide range of both undergraduate

More information

Guidance on IRB Continuing Review of Research

Guidance on IRB Continuing Review of Research NOTE: THIS GUIDANCE SUPERSEDES OHRP S JANUARY 15, 2007 GUIDANCE ENTITILED GUIDANCE ON CONTINUING REVIEW. CLICK HERE FOR THE JANUARY 15, 2007 GUIDANCE. Office for Human Research Protections Department of

More information

Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination

Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination 5.1. Recordkeeping Policy In accordance with federal regulations (45 CFR 46.115 and

More information

Email Address Co-Principal Investigator Information Co- Principal Investigator Faculty Staff Grad. Student Undergrad. Student

Email Address Co-Principal Investigator Information Co- Principal Investigator Faculty Staff Grad. Student Undergrad. Student Illinois State University Institutional Review Board Research with Human Subjects Protocol Submission Form IRB Number (Number to be completed by REC) Federal regulations and Illinois State University policy

More information

Principal Investigator and Sub Investigator Responsibilities

Principal Investigator and Sub Investigator Responsibilities Principal Investigator and Sub Investigator Responsibilities I. Purpose To define the roles and responsibilities of Principal Investigators conducting research at GRU. II. Definition The term Principal

More information

SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS

SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS BACKGROUND SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS The first priority of the SDCCD Institutional Review Board (IRB)

More information

EVALUATION BRIEF Understanding the Institutional Review Board (IRB) January 2008

EVALUATION BRIEF Understanding the Institutional Review Board (IRB) January 2008 1 Serving the public and non-profit sectors through independent program evaluation, applied research, and technical assistance. EVALUATION BRIEF Understanding the Institutional Review Board (IRB) January

More information

Research Institute Administration

Research Institute Administration PROTOCOL DEVIATIONS 229 1 of 7 PURPOSE The purpose of this policy is to define protocol deviations and the subsequent actions required by the Principal Investigator (PI) once a protocol deviation occurs

More information

Miami University: Human Subjects Research General Research Application Guidance

Miami University: Human Subjects Research General Research Application Guidance Miami University: Human Subjects Research General Research Application Guidance Use the accompanying Word template for completing the research description. You must provide sufficient information regarding

More information

University of Oklahoma Office of Human Research Participant Protection SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES

University of Oklahoma Office of Human Research Participant Protection SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES 1. POLICY SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES The purpose of this policy is to outline the qualifications and responsibilities of the principal investigator and key personnel who

More information

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Introduction The purpose of this module is to provide a basic understanding of the responsibilities of the principal

More information

HOSPITAL ADMINISTRATIVE POLICY

HOSPITAL ADMINISTRATIVE POLICY HOSPITAL ADMINISTRATIVE POLICY INSTITUTIONAL REVIEW BOARD GOVERNANCE POLICY Document No.: Revision: Original Date: Effective Date: NUH-HAP-ROF-004 00 08-Apr-2013 08-Apr-2013 : Description of Content/Change:

More information

SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS

SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS BACKGROUND SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS The first priority of the San Diego City College Research

More information

12.0 Investigator Responsibilities

12.0 Investigator Responsibilities v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,

More information

Evaluation Instrument for Accreditation January 1, 2015

Evaluation Instrument for Accreditation January 1, 2015 Evaluation Instrument for Accreditation January 1, 2015 Copyright 2002-2014 AAHRPP. All rights reserved. Use of the Evaluation Instrument for Accreditation The Evaluation Instrument for Accreditation is

More information

Considerations for Waivers of Informed Consent and Authorization

Considerations for Waivers of Informed Consent and Authorization Considerations for Waivers of Informed Consent and Authorization Contents: Waiver of Informed Consent... 1 Office for Human Research Protections (OHRP) regulations... 1 Government projects... 1 All other

More information

Nova Southeastern University IRB - Consent Form Checklist Version Date: 02/17/2010

Nova Southeastern University IRB - Consent Form Checklist Version Date: 02/17/2010 Nova Southeastern University IRB - Consent Form Checklist Version Date: 02/17/2010 This form is intended to assist researchers in creating consent and assent forms. Informed consent is one of the primary

More information

INSTRUCTIONS TO RESEARCHERS INSTITUTIONAL REVIEW BOARD HUMAN SUBJECTS

INSTRUCTIONS TO RESEARCHERS INSTITUTIONAL REVIEW BOARD HUMAN SUBJECTS INSTRUCTIONS TO RESEARCHERS INSTITUTIONAL REVIEW BOARD HUMAN SUBJECTS The Federal Requirement. As of 2001 Duquesne University maintains a relationship with federal research and funding agencies known as

More information

Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research

Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research 1. Objective: The objective of this SOP is to contribute to the effective functioning

More information

Ochsner Institutional Review Board (IRB) Written Procedures

Ochsner Institutional Review Board (IRB) Written Procedures Ochsner Institutional Review Board (IRB) Written Procedures Date of Revision: September 16, 2011 (click here for Revision History) Note: When possible, references and appendix material are hyperlinked

More information

Reporting of Adverse Events and Unanticipated Problems

Reporting of Adverse Events and Unanticipated Problems Reporting of Adverse Events and Unanticipated Problems Policy date: 12/2011 Purpose The purpose of this policy is to ensure that the review, reporting and analysis of adverse events and unanticipated problems

More information

INSTITUTIONAL COMPLIANCE PLAN

INSTITUTIONAL COMPLIANCE PLAN INSTITUTIONAL COMPLIANCE PLAN Responsible Party: Board of Trustees Contact: Institutional Compliance Office Original Effective Date: 02/16/2012 Last Revised Date: 10/13/2014 Contents I. SCOPE OF THE PLAN...

More information

Introduction to Institutional Review Boards (IRBs) Holly Taylor, MPH, PhD Johns Hopkins University

Introduction to Institutional Review Boards (IRBs) Holly Taylor, MPH, PhD Johns Hopkins University This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this

More information

To IRB, or Not to IRB? That Is the Question!

To IRB, or Not to IRB? That Is the Question! To IRB, or Not to IRB? That Is the Question! A presentation by Mary Sapp, Ph.D. Assistant Vice President, Planning & Institutional Research University of Miami and Thomas K. Martin, Ph.D. Associate Vice

More information

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities This Guidance Document is to ensure that investigators and research personnel recognize their responsibilities associated with the conduct of human subject research by outlining their responsibilities,

More information

AAHRPP Standards. Investigator Responsibilities for Research Involving Human Subjects

AAHRPP Standards. Investigator Responsibilities for Research Involving Human Subjects AAHRPP Standards Investigator Responsibilities for Research Involving Human Subjects Regulatory Landscape 2 AAHRPP OHRP FDA Pennington Louisiana Laws The Association for the Accreditation of Human Research

More information

Evaluation Instrument for Accreditation January 1, 2016

Evaluation Instrument for Accreditation January 1, 2016 Evaluation Instrument for Accreditation January 1, 2016 Copyright 2002-2014 AAHRPP. All rights reserved. Use of the Evaluation Instrument for Accreditation The Evaluation Instrument for Accreditation is

More information

OPERATING PROCEDURES

OPERATING PROCEDURES OPERATING PROCEDURES CATEGORY: RESEARCH AFFAIRS CODE: H-27A APPROVED: 8/17/2010 SUBJECT: PROCEDURES FOR CONDUCT OF CONVENED IMPLEMENTED: 11/2010 REPLACES: PAGE: 1 of 6 Please note: Definitions are found

More information

IRB Overview: Research and Paperwork

IRB Overview: Research and Paperwork UC DAVIS OFFICE OF RESEARCH IRB Overview: Research and Paperwork Miles McFann IRB Administration Outreach, Training, and Education Objectives IRB Responsibilities Knowledge of the Ethical Principles Definitions

More information

State University of New York at Canton Institutional Review Board. Sample Informed Consent Document

State University of New York at Canton Institutional Review Board. Sample Informed Consent Document State University of New York at Canton Institutional Review Board Sample Informed Consent Document The following sample informed consent document includes instructions to the person writing the document,

More information

Illinois State University Institutional Review Board Policy and Procedures Manual for the Protection of Human Research Subjects

Illinois State University Institutional Review Board Policy and Procedures Manual for the Protection of Human Research Subjects Illinois State University Institutional Review Board Policy and Procedures Manual for the Protection of Human Research Subjects Page I. The Basics of Human Subject Research Protection 2 A. Important Terms

More information

The Institutional Review Board (IRB) Manual

The Institutional Review Board (IRB) Manual The Institutional Review Board (IRB) Manual Institutional Review Board (IRB) Conflict of Interest Policy Purpose and Scope This Policy applies to all investigators at Boston Children s Hospital ( Children

More information

Reliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s)

Reliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s) Name of Organization Providing IRB Review: Stony Brook University ( SBU IRB ) Name of Institution Relying on the SBU IRB ( Institution ): Latest AAHRPP Accreditation Date (if applicable) OHRP Federal Wide

More information

The JSU IRB. IRB Membership

The JSU IRB. IRB Membership The JSU IRB The Institutional Review Board exists because federal regulations require that federal departments and federal agencies scrutinize all human subject research conducted or sponsored by each

More information

Document Template #1 Adult/General Informed Consent (Rev. 9/20/2011)

Document Template #1 Adult/General Informed Consent (Rev. 9/20/2011) Document Template #1 Adult/General Informed Consent (Rev. 9/20/2011) Consent Form for Participation in the Research Study Entitled XYZ (or can be written in the XYZ study ) Funding Source: List complete

More information

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB)

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB) March 1, 2006 M E M O R A N D U M F O R R E C O R D TO: FROM: SUBJECT: Deans Department Chairs Principal Investigators Brian Herman, Ph.D. Vice President for Research Investigator responsibilities for

More information

INSTITUTIONAL REVIEW BOARD

INSTITUTIONAL REVIEW BOARD INSTITUTIONAL REVIEW BOARD Policies and Procedures Manual January 2015 Revision 5.0 TABLE OF CONTENTS 1.0 Purpose, Regulatory Overview, and Institutional Policy 1.1 Introduction and Purpose 1.2 Laws, Regulations,

More information

Human Research Ethics Committee. Standard Operating Procedures

Human Research Ethics Committee. Standard Operating Procedures Human Research Ethics Committee Standard Operating Procedures Version: 19 July 2012 Contents 1. Appointment of Members... 1 2. Orientation of New Members... 3 3. Preparation of Agenda... 4 4. Conduct of

More information

NCS Rules of Governance

NCS Rules of Governance NCS Rules of Governance September 2003, Revised March 2007. Table of Contents Part I - Organization Article 1.1 Purpose Article 1.2 The United States National CAD Standard Article 1.3 Scope and Limit of

More information

Institutional Review Board

Institutional Review Board Institutional Review Board Ethical Principles of Informed Consent Informed Consent Guidelines The principle of respect for persons requires that people be given the opportunity to choose what will or will

More information

Human Subjects Research at OSU

Human Subjects Research at OSU Office of Responsible Research Practices 300 Research Foundation 1960 Kenny Road Columbus, OH 43210-1063 Human Subjects Research at OSU Phone (614) 688-8457 Fax (614) 688-0366 www.orrp.osu.edu Behavioral

More information

INSTITUTIONAL REVIEW BOARD OTTERBEIN UNIVERSITY

INSTITUTIONAL REVIEW BOARD OTTERBEIN UNIVERSITY INSTITUTIONAL REVIEW BOARD OTTERBEIN UNIVERSITY GUIDELINES FOR SUBMISSION OF PROTOCOLS CONTENTS Statement of Purpose Criteria for Review Submission Procedure Expedited Review Sample Informed Consent Models

More information

INSTITUTIONAL REVIEW BOARD ( IRB ) RECIPROCITY AGREEMENT AND MEMORANDUM OF UNDERSTANDING

INSTITUTIONAL REVIEW BOARD ( IRB ) RECIPROCITY AGREEMENT AND MEMORANDUM OF UNDERSTANDING INSTITUTIONAL REVIEW BOARD ( IRB ) RECIPROCITY AGREEMENT AND MEMORANDUM OF UNDERSTANDING 1) PURPOSE: This IRB Reciprocity Agreement and Memorandum of Understanding ("MOU") sets forth the agreement among

More information

Instructions for Form: Application for Claim of Exemption

Instructions for Form: Application for Claim of Exemption Instructions for Form: Application for Claim of Exemption In order to decide whether your activity involves research that may be reviewed and approved at the exempt level, review the following information.

More information

This policy applies to all clinical research conducted at Beaumont Health System.

This policy applies to all clinical research conducted at Beaumont Health System. CLINICAL RESEARCH QUALITY AND PROCESS IMPROVEMENT PROGRAM 113 1 of 6 PURPOSE Prior The purpose of this policy is to provide an overview of the Clinical Research Quality and Process Improvement Program

More information

Wake Forest School of Medicine. Human Research Protection Program and Institutional Review Board. Polices and Procedures

Wake Forest School of Medicine. Human Research Protection Program and Institutional Review Board. Polices and Procedures Wake Forest School of Medicine Human Research Protection Program and Institutional Review Board Polices and Procedures Contents 1.0 Ethical and Regulatory Mandates for the Protection of Human Research

More information

POLICY ON INDIVIDUAL CONFLICTS OF INTEREST IN RESEARCH & PRODUCT DEVELOPMENT

POLICY ON INDIVIDUAL CONFLICTS OF INTEREST IN RESEARCH & PRODUCT DEVELOPMENT POLICY ON INDIVIDUAL CONFLICTS OF INTEREST IN RESEARCH & PRODUCT DEVELOPMENT For the University of Maryland, Baltimore County (UMBC) Policy No. II-8.00.05 I. INTRODUCTION A. General. A conflict of interest

More information

The University of North Carolina at Greensboro Procedures for Human Research Protection

The University of North Carolina at Greensboro Procedures for Human Research Protection The University of North Carolina at Greensboro Procedures for Human Research Protection Spring 2013 i 1 Mission... 1 1.1 Introduction... 1 1.2 Ethical Principles: The Belmont Report... 2 2 Definitions...

More information

Use of Vertebrate Animals in Research and Teaching

Use of Vertebrate Animals in Research and Teaching UNIVERSITY OF CALIFORNIA, IRVINE OFFICE OF RESEARCH ADMINISTRATION Use of Vertebrate Animals in Research and Teaching Research Policy Section IV.B. - Research Responsibilities: Animal Subjects Sections

More information

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues This guidance represents

More information

BJC HealthCare CORPORATE COMPLIANCE POLICY. APPLIES TO: BJC HealthCare and all BJC Members and Affiliates

BJC HealthCare CORPORATE COMPLIANCE POLICY. APPLIES TO: BJC HealthCare and all BJC Members and Affiliates Page 1 of 11 BJC HealthCare CORPORATE COMPLIANCE POLICY APPLIES TO: BJC HealthCare and all BJC Members and Affiliates TITLE: BJC HealthCare Financial Conflict of Interest in Research Policy NUMBER: 9.1

More information

Article I: Objectives

Article I: Objectives Graduate Group in Human Development Bylaws Graduate Group in Child Development Bylaws Administrative Home: Department of Human & Community Development Revision: July 28, 2003 Graduate Council approval

More information

Institutional Review Board (IRB)

Institutional Review Board (IRB) Institutional Review Board (IRB) POLICIES AND PROCEDURES MANUAL IRB #1: Lubbock/Odessa IRB #2: Amarillo/Dallas IRB #3: El Paso IRB #4: El Paso Effective Date: 11/01/2011 REVISION October, 2011-1 - Table

More information

INSTITUTIONAL REVIEW BOARD (IRB) REVIEW FORM FOR PROJECTS USING HUMAN SUBJECTS

INSTITUTIONAL REVIEW BOARD (IRB) REVIEW FORM FOR PROJECTS USING HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD (IRB) REVIEW FORM FOR PROJECTS USING HUMAN SUBJECTS Investigators are responsible for ensuring that the rights and welfare of human subjects participating in research activities

More information

Short title 1. This Act may be cited as the Accountants Act. Interpretation 2. In this Act, unless the context otherwise requires "accounting

Short title 1. This Act may be cited as the Accountants Act. Interpretation 2. In this Act, unless the context otherwise requires accounting Short title 1. This Act may be cited as the Accountants Act. Interpretation 2. In this Act, unless the context otherwise requires "accounting corporation" means a company approved as an accounting corporation

More information

USE OF HUMAN SUBJECTS IN RESEARCH PRESENTED BY BRIAN WEIMER TULANE UNIVERSITY RESEARCH COMPLIANCE OFFICER

USE OF HUMAN SUBJECTS IN RESEARCH PRESENTED BY BRIAN WEIMER TULANE UNIVERSITY RESEARCH COMPLIANCE OFFICER USE OF HUMAN SUBJECTS IN RESEARCH PRESENTED BY BRIAN WEIMER TULANE UNIVERSITY RESEARCH COMPLIANCE OFFICER June 14, 2011 Objectives of Presentation What is the role of the Research Compliance Officer? Why

More information

Determining who the investigators are and who the principal investigator is:

Determining who the investigators are and who the principal investigator is: Responsibilities of the IRBs of the Health System and University for Research Conducted by Investigators from a Combination of the Following Institutions: the Health System, University, and Medical School

More information

Application Guide to assist completion of the ACC Research Ethics Committee Application Template

Application Guide to assist completion of the ACC Research Ethics Committee Application Template Application Guide to assist completion of the ACC Research Ethics Committee Application Template A number of guiding principles govern the review of research proposals. The following provide guidance but

More information

STT ENVIRO CORP. (the Company ) CHARTER OF THE CORPORATE GOVERNANCE AND NOMINATING COMMITTEE. As amended by the Board of Directors on May 10, 2012

STT ENVIRO CORP. (the Company ) CHARTER OF THE CORPORATE GOVERNANCE AND NOMINATING COMMITTEE. As amended by the Board of Directors on May 10, 2012 STT ENVIRO CORP. (the Company ) CHARTER OF THE CORPORATE GOVERNANCE AND NOMINATING COMMITTEE PURPOSE AND SCOPE As amended by the Board of Directors on May 10, 2012 The primary function of the Committee

More information

Process: Federal Compliance Program. Information for Institutions and Peer Reviewers

Process: Federal Compliance Program. Information for Institutions and Peer Reviewers Federal Compliance Program Information for Institutions and Peer Reviewers This set of materials should be used by institutions preparing for and teams conducting evaluations for initial candidacy and

More information

IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM

IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM 1 IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM Wednesday, April 23, 2014 Cohen Lounge Hila Berger, MPH, CIP Research Compliance Administrator Amy Krenzer, CIP IRB Coordinator 2 Objectives What is the IRB

More information

Texas A&M International University

Texas A&M International University Texas A&M International University Institutional Review Board Policy and Procedures Manual Updated: 12 November 2007 TAMIU IRB Policy Manual Page 1 Table of Contents Page 1. General Overview 4 1.1 Institutional

More information

STANDARD OPERATING PROCEDURES

STANDARD OPERATING PROCEDURES Institutional Review Board STANDARD OPERATING PROCEDURES CONSTITUTING THE ETHICS REVIEW COMMITTEE FOR BIOMEDICAL RESEARCH SOP Number 001 Version No. 1.0, September 2012 SOP Status Final Effective by :

More information

Nova Southeastern University Institutional Review Board Policies and Procedures

Nova Southeastern University Institutional Review Board Policies and Procedures Nova Southeastern University Institutional Review Board Policies and Procedures Monitoring of Approved Research, Approval Duration, and Continuing Review Effective 03/08/2007; Revised 10/14/2010; 8/29/2011;

More information

IRB Submissions and Human Subjects Research Compliance. Georgia Health Sciences University

IRB Submissions and Human Subjects Research Compliance. Georgia Health Sciences University IRB Submissions and Human Subjects Research Compliance Offi f H R hp t ti Office of Human Research Protection Georgia Health Sciences University Objectives Identify the steps required to submit a protocol

More information

CASE WESTERN RESERVE UNIVERSITY FRANCES PAYNE BOLTON SCHOOL OF NURSING BYLAWS OF THE FACULTY ARTICLE I PURPOSE OF THE BYLAWS

CASE WESTERN RESERVE UNIVERSITY FRANCES PAYNE BOLTON SCHOOL OF NURSING BYLAWS OF THE FACULTY ARTICLE I PURPOSE OF THE BYLAWS 1978 79 1979 80 1980 81 1981 82 1982 83 1985 86 amended 5/92 approved by faculty senate 5/92 amended 1/95 approved by faculty senate 4/95 corrections to the 11/02 amendments 12/12/02 approved by faculty

More information

TABLE OF CONTENTS Licensure and Accreditation of Institutions and Programs of Higher Learning ARTICLE ONE Policies and Procedures

TABLE OF CONTENTS Licensure and Accreditation of Institutions and Programs of Higher Learning ARTICLE ONE Policies and Procedures Board of Governors for Higher Education Sec. 10a-34 page 1 (12-96) TABLE OF CONTENTS Licensure and Accreditation of Institutions and Programs of Higher Learning ARTICLE ONE Policies and Procedures Introduction....

More information

Standard Operating Procedures

Standard Operating Procedures Standard Operating Procedures Ffff H a r v a r d L o n g w o o d M e d i c a l A r e a Office of Human Research Administration 90 Smith St. Suite 335 Boston, MA 02120 617-432-3071/ 617-432-2157 www.hsph.harvard.edu/ohra

More information

Corporate Governance Guidelines

Corporate Governance Guidelines Corporate Governance Guidelines A. Introduction The Board of Directors (the Board ) of (the Company ) has adopted these corporate governance guidelines to provide a framework within which the Board may

More information

PART II - CODE OF ORDINANCES GENERAL ORDINANCES Chapter 2 - ADMINISTRATION ARTICLE XVI. - BOARDS, COUNCILS, COMMISSIONS AND AUTHORITIES

PART II - CODE OF ORDINANCES GENERAL ORDINANCES Chapter 2 - ADMINISTRATION ARTICLE XVI. - BOARDS, COUNCILS, COMMISSIONS AND AUTHORITIES DIVISION 11. CITIZEN REVIEW BOARD Sec. 2-2201. Establishment of the Atlanta Citizen Review Board. Sec. 2-2202. Appointment of members. Sec. 2-2203. Composition of board. Sec. 2-2204. Time limit on appointments.

More information

Department of Defense INSTRUCTION. Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

Department of Defense INSTRUCTION. Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research Department of Defense INSTRUCTION NUMBER 3216.02 November 8, 2011 USD(AT&L) SUBJECT: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research References: See Enclosure

More information

ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014

ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014 ST. MICHAEL S HOSPITAL Guidelines for Reporting Serious Adverse Events / Unanticipated Problems to the SMH Research Ethics Board (REB) July 09, 2014 1. Introduction The St. Michael s Hospital (SMH) REB

More information

Winthrop University. Institutional Biosafety Committee Policy and Procedures

Winthrop University. Institutional Biosafety Committee Policy and Procedures Winthrop University Institutional Biosafety Committee Policy and Procedures MISSION STATEMENT The Institutional Biosafety Committee (IBC) oversees the safety of research and classroom projects involving

More information

CDC Faculty/Student Research/Observation Request

CDC Faculty/Student Research/Observation Request CDC Faculty/Student Research/Observation Request Date of Form Submission: Approx. Dates of Research/Observation: Faculty: Student Researchers: Course -- Department, Name and Number: # Students Who Will

More information

Appendix A - IPC regulations governing the procedures for dealing with complaints regarding alleged breaches of the IPC Code of Ethics

Appendix A - IPC regulations governing the procedures for dealing with complaints regarding alleged breaches of the IPC Code of Ethics Appendix A - IPC regulations governing the procedures for dealing with complaints regarding alleged breaches of the IPC Code of Ethics June 2009 International Paralympic Committee Adenauerallee 212-214

More information

BYLAWS SCHOOL OF LAW UNIVERSITY OF WASHINGTON Approved 4/3/13

BYLAWS SCHOOL OF LAW UNIVERSITY OF WASHINGTON Approved 4/3/13 BYLAWS SCHOOL OF LAW UNIVERSITY OF WASHINGTON Approved 4/3/13 In order to exercise the powers granted under the Faculty Code, Section 23-43, and to advise the Dean as required in Section 23-43B in an orderly

More information

2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14

2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14 2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14 NDSU research may involve the collaboration or assistance of other research institutions, schools, hospitals, clinics, private

More information

Human Subjects Research (HSR) Series

Human Subjects Research (HSR) Series Human Subjects Research (HSR) Series CITI Program s HSR series consists of modules from two basic tracks, Biomedical (Biomed) and Social- Behavioral- Educational (SBE), and a set of Additional Modules

More information

CONSTITUTION OF THE FACULTY SENATE COPPIN STATE UNIVERSITY

CONSTITUTION OF THE FACULTY SENATE COPPIN STATE UNIVERSITY 1 CONSTITUTION OF THE FACULTY SENATE COPPIN STATE UNIVERSITY The Faculty Senate of Coppin State University, in accordance with the By-Laws of the University System of Maryland, shall serve as the official

More information

SCHEDULE "C" to the MEMORANDUM OF UNDERSTANDING BETWEEN ALBERTA HEALTH SERVICES AND THE ALBERTA MEDICAL ASSOCIATION (CMA ALBERTA DIVISION)

SCHEDULE C to the MEMORANDUM OF UNDERSTANDING BETWEEN ALBERTA HEALTH SERVICES AND THE ALBERTA MEDICAL ASSOCIATION (CMA ALBERTA DIVISION) SCHEDULE "C" to the MEMORANDUM OF UNDERSTANDING BETWEEN ALBERTA HEALTH SERVICES AND THE ALBERTA MEDICAL ASSOCIATION (CMA ALBERTA DIVISION) ELECTRONIC MEDICAL RECORD INFORMATION EXCHANGE PROTOCOL (AHS AND

More information

CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE

CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH OFFICE FOR PROTECTION FROM RESEARCH RISKS PART 46 PROTECTION OF HUMAN SUBJECTS

More information

GRADUATE FACULTY GUIDELINES

GRADUATE FACULTY GUIDELINES GRADUATE FACULTY GUIDELINES Members of Graduate Faculty at the University of Northern Colorado are selected from the general faculty. The UNC Faculty Constitution, adopted on June 23, 1983, established

More information

ETHICAL CONDUCT AND PROFESSIONAL PRACTICE: PRINCIPLES AND STANDARDS FOR MEMBERS OF THE BRITISH COLUMBIA ASSOCIATION OF SCHOOL PSYCHOLOGISTS

ETHICAL CONDUCT AND PROFESSIONAL PRACTICE: PRINCIPLES AND STANDARDS FOR MEMBERS OF THE BRITISH COLUMBIA ASSOCIATION OF SCHOOL PSYCHOLOGISTS ETHICAL CONDUCT AND PROFESSIONAL PRACTICE: PRINCIPLES AND STANDARDS FOR MEMBERS OF THE BRITISH COLUMBIA ASSOCIATION OF SCHOOL PSYCHOLOGISTS March 2010 Preamble Ethical Principles define the ethical responsibility

More information

Humber College Institute of Technology & Advanced Learning. Program Advisory Committee. Procedure Manual

Humber College Institute of Technology & Advanced Learning. Program Advisory Committee. Procedure Manual Humber College Institute of Technology & Advanced Learning Program Advisory Committee Procedure Manual Message from the President On behalf of Humber College Institute of Technology & Advanced Learning,

More information

Academic Council Policies and Procedures

Academic Council Policies and Procedures Academic Council Policies and Procedures Academic Council Policy and Procedures: Version 14 April 22 th 2014 1 Table of Contents Academic Council Policies Appointment, Promotion & Tenure Policies Faculty

More information

CHAPTER 5 STAKEHOLDERS: THEIR INTERESTS, CONCERNS, AND RESPONSIBILITIES

CHAPTER 5 STAKEHOLDERS: THEIR INTERESTS, CONCERNS, AND RESPONSIBILITIES CHAPTER 5 STAKEHOLDERS: THEIR INTERESTS, CONCERNS, AND RESPONSIBILITIES Key Points: Each worker study involves multiple stakeholders in addition to the researcher and worker. Stakeholders interests in

More information

Submission Date: Project Start Date: Approximate Project End Date:

Submission Date: Project Start Date: Approximate Project End Date: APPLICATION FOR INITIAL APPROVAL Submission Date: Project Start Date: Approximate Project End Date: Research Protocol Title: Principal Investigator: Research Study Contact: Email: Institution: Phone: SENIOR/KEY

More information

Policy of the National Institute of Nursing Research for Data and Safety Monitoring of Extramural Clinical Trials

Policy of the National Institute of Nursing Research for Data and Safety Monitoring of Extramural Clinical Trials Policy of the National Institute of Nursing Research for Data and Safety Monitoring of Extramural Clinical Trials Purpose and Scope This policy sets forth the National Institute of Nursing Research (NINR)

More information

Institution: World Learning Inc. IRB organization number: IORG IRB registration number: IRB Expires: 9 December 2017

Institution: World Learning Inc. IRB organization number: IORG IRB registration number: IRB Expires: 9 December 2017 DR SCHOOL FOR INTERNATIONAL TRAINING (SIT) HUMAN SUBJECTS RESEARCH POLICY June 22, 2016 Institution: World Learning Inc. IRB organization number: IORG0004408 IRB registration number: IRB00005219 Expires:

More information

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research FDA Audit Guidelines University of Miami Office of the Vice Provost for Research FDA Audit Guidelines Contents INTRODUCTION 3 VICE PROVOST FOR RESEARCH ROLE IN FDA AUDITS 3 PRE-AUDIT REVIEW 3 INSPECTION

More information

INSTITUTIONAL REVIEW BOARD HANDBOOK Guide for Research involving Human Subjects Effective June 2016 with the Implementation of IRBManager

INSTITUTIONAL REVIEW BOARD HANDBOOK Guide for Research involving Human Subjects Effective June 2016 with the Implementation of IRBManager 2015-16 INSTITUTIONAL REVIEW BOARD HANDBOOK Guide for Research involving Human Subjects Effective June 2016 with the Implementation of IRBManager Table of Contents Page Frequently Asked Questions 2 Guidelines

More information

BYLAWS OF THE FACULTY College of Arts and Sciences Georgia State University

BYLAWS OF THE FACULTY College of Arts and Sciences Georgia State University BYLAWS OF THE FACULTY College of Arts and Sciences Georgia State University 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 ARTICLE I. PURPOSES Section 1.

More information

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE

GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's

More information

Bradley D. Powell, PhD NOTICE OF PRIVACY PRACTICES: Effective June 1, 2004

Bradley D. Powell, PhD NOTICE OF PRIVACY PRACTICES: Effective June 1, 2004 Bradley D. Powell, PhD NOTICE OF PRIVACY PRACTICES: Effective June 1, 2004 A Summary of the Provisions of the Health Insurance Portability and Accountability Act ( HIPAA ) Privacy Rule (45 C.F.R. parts

More information

Tax Agent Services Act 2009

Tax Agent Services Act 2009 Tax Agent Services Act 2009 No. 13, 2009 An Act to establish the Tax Practitioners Board and to provide for the registration of tax agents and BAS agents, and for related purposes Note: An electronic version

More information

RULES AND BYLAWS SCHOOL OF COMPUTER SCIENCE UNIVERSITY OF NEVADA, LAS VEGAS

RULES AND BYLAWS SCHOOL OF COMPUTER SCIENCE UNIVERSITY OF NEVADA, LAS VEGAS RULES AND BYLAWS SCHOOL OF COMPUTER SCIENCE UNIVERSITY OF NEVADA, LAS VEGAS SECTION I - The School Faculty 1.1 Responsibilities - The School Faculty, under the direction of the Director, shall have authority

More information

Adventist HealthCare, Inc.

Adventist HealthCare, Inc. IRB POLICY ON HUMAN RESEARCH PROTECTION (HRP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING Collaborative Institutional Training Initiative (CITI) Requirements at Adventist Healthcare, Inc. I. Required Human

More information

Constitution Amendment

Constitution Amendment Meeting and date Title Summary of paper JOINT MEETING OF THE BOARD OF DIRECTORS AND COUNCIL OF GOVERNORS 9 JUNE 2016 Constitution Amendment This report invites the Board of Directors and the Council of

More information